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R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rituximab
Mitoxantrone hydrochloride liposome
Cyclophosphamide
Vincristine/Vindesine
Prednisone
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring DLBCL, R-CMOP, Mitoxantrone liposome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To participate in the study voluntarily and sign the informed consent (ICF); 18 years ≤ age ≤80 years; Expected survival time ≥3 months; Initial DLBCL confirmed by histopathology; There must be at least one evaluable or measurable lesion in line with Lugano2014 criteria: lymph node lesion, the length and diameter of detectable lymph node must be greater than 1.5cm; For non-lymph node lesions, the diameter of extrinsic lesions should be > 1.0cm; ECOG score 0~2; Bone marrow function: neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥80 g/L (neutrophil count ≥1.0×10^9/L, platelet count ≥50×10^9/L, hemoglobin ≥75g/L in patients with bone marrow involvement); Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion); Cardiac function: 50% ≤ LVEF ≤ 55%, or LVEF>55% patients with cardiovascular disease (including left ventricular enlargement (left ventricular diameter: male>60mm; female>55mm), controllable arrhythmia (first degree atrioventricular block, second degree type I atrioventricular block, atrial fibrillation, atrial flutter, ventricular premature beats (<4000 times/24h, mainly single)), myocarditis, pericarditis, structural heart disease, etc.). Exclusion Criteria: Hypersensitivity to any study drug or its components; Uncontrollable systemic diseases (such as progressive infection, uncontrollable hypertension, diabetes, etc.); Cardiac function and disease conform to one of the following conditions: Long QTc syndrome or QTc interval >480 ms; Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block; New York College of Cardiology Grade ≥ III; A history of acute myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmias or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction abnormalities within the 6 months prior to treatment. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^4 copies /mL; HCV RNA over 1x10^4 copies /mL); Human immunodeficiency virus (HIV) infection (HIV antibody positive); Past or present co-existing malignancies (other than non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past five years); Had primary or secondary central nervous system (CNS) lymphoma or had a history of CNS lymphoma at the time of recruitment Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures; Other researchers judged that it was not suitable to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    R-CMOP

    Arm Description

    R-CMOP:Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone

    Outcomes

    Primary Outcome Measures

    Objective Response Rate(ORR)
    Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy

    Secondary Outcome Measures

    Complete remission rate(CRR)
    Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy
    Duration of remission(DOR)
    Time from reaching CR or PR for the first time to disease progression
    Progression-Free-Survival rate
    from date of inclusion to date of progression, relapse, or death from any cause
    Overall survival rate
    from the date of inclusion to date of death, irrespective of cause
    Adverse events (AE)
    The safety of the drug was evaluated by NCI-CTC AE 5.0 standard

    Full Information

    First Posted
    March 9, 2023
    Last Updated
    March 9, 2023
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05777369
    Brief Title
    R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma
    Official Title
    An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of R-CMOP regimen based on mitoxantrone hydrochloride liposome injection in the treatment of newly diagnosed diffuse large B-cell lymphoma (DLBCL) based on cardiac function screening
    Detailed Description
    Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. Based on the cardiac safety and efficacy of mitoxantrone liposome, the R-CMOP scheme based on Mitoxantrone liposome for the treatment of initial DLBCL based on cardiac function screening has sufficient theoretical basis and is worth exploring.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diffuse Large B-cell Lymphoma
    Keywords
    DLBCL, R-CMOP, Mitoxantrone liposome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    R-CMOP
    Arm Type
    Experimental
    Arm Description
    R-CMOP:Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone
    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab
    Intervention Description
    375 mg/m2, d0
    Intervention Type
    Drug
    Intervention Name(s)
    Mitoxantrone hydrochloride liposome
    Intervention Description
    18 mg/m2, d1
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Description
    750 mg/m2, d1
    Intervention Type
    Drug
    Intervention Name(s)
    Vincristine/Vindesine
    Intervention Description
    Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone
    Intervention Description
    60 mg/m2, d1~d5
    Primary Outcome Measure Information:
    Title
    Objective Response Rate(ORR)
    Description
    Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy
    Time Frame
    up to 6 cycles of chemotherapy (each cycle is 21 days)
    Secondary Outcome Measure Information:
    Title
    Complete remission rate(CRR)
    Description
    Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy
    Time Frame
    up to 6 cycles of chemotherapy (each cycle is 21 days)
    Title
    Duration of remission(DOR)
    Description
    Time from reaching CR or PR for the first time to disease progression
    Time Frame
    up to 6 cycles of chemotherapy (each cycle is 21 days)
    Title
    Progression-Free-Survival rate
    Description
    from date of inclusion to date of progression, relapse, or death from any cause
    Time Frame
    1 year
    Title
    Overall survival rate
    Description
    from the date of inclusion to date of death, irrespective of cause
    Time Frame
    1 year
    Title
    Adverse events (AE)
    Description
    The safety of the drug was evaluated by NCI-CTC AE 5.0 standard
    Time Frame
    From the first day of medication to 28 days after the last dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To participate in the study voluntarily and sign the informed consent (ICF); 18 years ≤ age ≤80 years; Expected survival time ≥3 months; Initial DLBCL confirmed by histopathology; There must be at least one evaluable or measurable lesion in line with Lugano2014 criteria: lymph node lesion, the length and diameter of detectable lymph node must be greater than 1.5cm; For non-lymph node lesions, the diameter of extrinsic lesions should be > 1.0cm; ECOG score 0~2; Bone marrow function: neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥80 g/L (neutrophil count ≥1.0×10^9/L, platelet count ≥50×10^9/L, hemoglobin ≥75g/L in patients with bone marrow involvement); Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion); Cardiac function: 50% ≤ LVEF ≤ 55%, or LVEF>55% patients with cardiovascular disease (including left ventricular enlargement (left ventricular diameter: male>60mm; female>55mm), controllable arrhythmia (first degree atrioventricular block, second degree type I atrioventricular block, atrial fibrillation, atrial flutter, ventricular premature beats (<4000 times/24h, mainly single)), myocarditis, pericarditis, structural heart disease, etc.). Exclusion Criteria: Hypersensitivity to any study drug or its components; Uncontrollable systemic diseases (such as progressive infection, uncontrollable hypertension, diabetes, etc.); Cardiac function and disease conform to one of the following conditions: Long QTc syndrome or QTc interval >480 ms; Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block; New York College of Cardiology Grade ≥ III; A history of acute myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmias or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction abnormalities within the 6 months prior to treatment. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^4 copies /mL; HCV RNA over 1x10^4 copies /mL); Human immunodeficiency virus (HIV) infection (HIV antibody positive); Past or present co-existing malignancies (other than non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past five years); Had primary or secondary central nervous system (CNS) lymphoma or had a history of CNS lymphoma at the time of recruitment Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures; Other researchers judged that it was not suitable to participate in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    JinHua Liang, M.D
    Phone
    15952032421
    Email
    1151525490@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Xu, PhD& MD
    Phone
    862568136034
    Email
    xuwei10000@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei Xu, PhD& MD
    Organizational Affiliation
    The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma

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